Stakeholder Opinions: Irritable Bowel Syndrome - Potentially profitable market is open for the taking

Table of Contents

• ABOUT DATAMONITOR HEALTHCARE
  • About the CNS pharmaceutical analysis team
• CHAPTER 1 EXECUTIVE SUMMARY
  • Scope of the analysis
  • Datamonitor insight into the irritable bowel syndrome market
  • Contributing experts
• CHAPTER 2 EPIDEMIOLOGY AND PATIENT SEGMENTATION
  • Definition of disorder
    • Irritable bowel syndrome is a functional gastrointestinal disorder
    • Diagnostic criteria separate this chronic condition from transient gut symptoms
  • Etiology
    • Irritable bowel syndrome is best considered as an interaction of biological and psychosocial factors
  • Prevalence of irritable bowel syndrome
    • A standardized approach is needed in epidemiological studies
    • Over 50 million adults suffer from IBS across the US and
  • Segmentation of the irritable bowel syndrome population
    • Segmentation by symptoms
      • Irritable bowel syndrome can be sub-classified based on predominant stool form
      • Alternating irritable bowel syndrome is the most common subtype reported
      • Abdominal pain is the most common symptom of irritable bowel syndrome
    • Segmentation by severity
      • Only a third of patients have moderate to severe irritable bowel syndrome
    • Segmentation by sex and age
      • The female-to-male ratio of IBS in the population is close to two
  • Co-morbidities of irritable bowel syndrome
    • High co-morbidity with other disorders
• CHAPTER 3 PRESENTATION AND DIAGNOSIS
  • Presentation
    • Patient presentation rates are low
    • Abdominal pain is a common reason for consulting a physician
  • Diagnosis
    • There is no simple test for irritable bowel syndrome so diagnosis is based on symptoms
      • The Manning criteria helped identify the symptoms suggestive of irritable bowel syndrome
      • The Rome criteria have superseded the Manning criteria
      • Rome III attempts to deal with confusion regarding consistency of stools
      • Quality of life measures are useful for assessing severity
      • Within clinical practice, measures are rarely used to assess severity
    • Many irritable bowel syndrome sufferers remain undiagnosed
  • Irritable bowel syndrome management and referral patterns
    • The majority of patients present and are managed by primary care
• CHAPTER 4 CURRENT TREATMENT
  • There is no cure for irritable bowel syndrome
  • Treatment guidelines
    • Guidelines recommend treatment strategy is based on nature and severity of symptoms
    • US guidelines are based on consensus documents and reviews of existing studies
    • Japanese guidelines
    • European guidelines suggest a similar approach to those in the US
  • Non-pharmacological management
    • Psychological and behavioral treatment
  • Pharmacological management
    • Pharmacological therapies are not normally recommended unless non-pharmacological therapies have proved ineffective
    • Laxatives are widely used in constipation-predominant irritable bowel syndrome
    • Antidiarrheal agents are widely used in diarrhea-predominant irritable bowel syndrome
    • Antispasmodics are the most common treatment for abdominal pain
    • Antidepressants treat multiple symptoms of irritable bowel syndrome
    • Serotonergic agents are a new approach to treating irritable bowel syndrome
      • Lotronex (alosetron)
      • Zelnorm (tegaserod)
• CHAPTER 5 UNMET NEEDS AND MARKET OPPORTUNITIES
  • Diagnostic unmet needs
    • Public understanding of irritable bowel syndrome is poor
      • Improved patient-physician communication is a key goal
      • Disease awareness programs and celebrity endorsement drive public awareness
      • Direct-to-consumer advertising has helped increase awareness and presentation rates
    • Physicians frequently do not recognize irritable bowel syndrome as a ' distinct' disease
      • Continuing physician education is needed to improve diagnosis
      • Development of simple diagnostic guidelines could aid diagnosis
  • Therapeutic unmet needs
    • Few primary care physicians follow current treatment guidelines in clinical practice
    • Efficacy of current pharmacological therapies is unclear
    • Patient satisfaction with current therapies is low
• CHAPTER 6 NEW PRODUCT DEVELOPMENT
  • Clinical trial design
    • Issues with and limitations of previous clinical trials for irritable bowel syndrome
    • EMEA has provided guidance on clinical trial design
      • A different trial design for short-term and long-term treatments is advocated
      • A broad spectrum of irritable bowel syndrome patients who meet Rome II criteria should be included
      • Primary and secondary efficacy endpoints should be included
  • Impact of safety issues with marketed therapies for future therapies
  • Pipeline in 2007
    • Pipeline overview
    • Key Phase III pipeline drugs
      • Cilansetron (KC-9946)
      • Ramosetron (YM-060)
      • Renzapride (ATL-1251)
      • Dexloxiglumide
      • Lubiprostone (SP1-0211)
      • Other pipeline drugs
• BIBLIOGRAPHY
  • Journal papers
  • Websites
• APPENDIX
  • Contributing experts
  • About Datamonitor
    • About Datamonitor Healthcare
    • About the Central Nervous System analysis team
    • Disclaimer
  • List of Tables
    • Table 1: Diagnostic criteria* for irritable bowel syndrome (Rome III criteria, C1)
    • Table 2: Summary of IBS epidemiology study design and results across the seven major markets, 2001-06
    • Table 3: Summary of IBS epidemiology study design and results for selected countries outside US, Japan and 5EU, 2004-06
    • Table 4: Prevalence of IBS in the US and 5EU markets, 2007
    • Table 5: Subtyping irritable bowel syndrome by predominant stool pattern
    • Table 6: The Bristol Stool Form Scale
    • Table 7: Proportion of sufferers with subtypes
    • Table 8: Subtyping of irritable bowel syndrome: current sufferers with no formal diagnosis
    • Table 9: The Manning criteria
    • Table 10: Features used to subclassify irritable bowel syndrome
    • Table 11: Type of healthcare professional seen for irritable bowel syndrome at any stage: percentage of subjects with current symptoms
    • Table 12: Components of the treatment strategy: US medical position statement for irritable bowel syndrome
    • Table 13: British Society of Gastroenterology guidelines for treatment of irritable bowel syndrome
    • Table 14: Pharmacological therapies used for the management of irritable bowel syndrome
    • Table 15: R&D pipeline in irritable bowel syndrome, 2007
  • List of Figures
    • Figure 1: Interaction between the brain, bowel and environment
    • Figure 2: Two-dimensional display of the four possible irritable bowel subtypes according to bowel form at a particular point in time
    • Figure 3: Novartis patient information website on irritable bowel syndrome